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BCX4161 · 4 trials · 2 indications
An angioedema attack was defined as swelling at any location reported by participant, which had no swelling earlier. Total number of confirmed attacks during the treatment period standardized to a weekly attack-rate to adjust for the total duration of treatment. The attack rate was derived for each participant by treatment period. The weekly attack rate was equal to the total number of confirmed attacks during a treatment period divided by the duration of the treatment (in days) times 7 days.
| Arm | Type | Description |
|---|---|---|
| BCX4161 300 mg three times daily | EXPERIMENTAL | Three BCX4161 capsules (100 mg) and two placebo capsules to be taken three times daily by mouth |
| BCX4161 500 mg three times daily | EXPERIMENTAL | Five BCX4161 capsules (100 mg) to be taken three times daily by mouth |
| Placebo three times daily | PLACEBO_COMPARATOR | Five placebo capsules to be taken three times daily by mouth |
| BCX4161 | ACTIVE_COMPARATOR | 400 mg TID for 28 days |
| Placebo | PLACEBO_COMPARATOR | TID for 28 days |
| [14C] BCX4161 | EXPERIMENTAL | Includes a radiolabelled dose of \[14C\] BCX4161 and unlabelled BCX4161 |
| Treatment A | EXPERIMENTAL | BCX4161 400 mg formulated as hard gelatin capsules given orally under fasting conditions x1 |
| Treatment B | EXPERIMENTAL | BCX4161 400 mg formulated as soft gelatin capsules given orally under fasting conditions x1 |
| Treatment C | EXPERIMENTAL | BCX4161 400 mg formulated as soft gelatin capsules given orally after a high-fat breakfast x1 |
| Name | Type | Description |
|---|---|---|
| BCX4161 | DRUG | - |
| Placebo | DRUG | - |
Key Inclusion Criteria: 1. A clinical diagnosis of HAE type I or II 2. Documented HAE attacks within a defined calendar period; in the absence of documented HAE attacks, participants will be required to enter a run-in period to document attacks 3. Access to acute attack medications 4. Sexually acti...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Intellia Therapeutics, Inc. | NTLA | 3 | PHASE3 | NTLA-2002, Normal Saline Administration |
| BioCryst Pharmaceuticals, Inc. | BCRX | 2 | PHASE3 | Berotralstat |
| Ionis Pharmaceuticals, Inc. | IONS | 1 | PHASE3 | Donidalorsen |
| Pharvaris N.V. | PHVS | 1 | PHASE2 | deucrictibant |
| BioMarin Pharmaceutical Inc. | BMRN | 1 | PHASE1 | Dose 1 of BMN 331 |
| Astria Therapeutics, Inc. | ATXS | 1 | PHASE2 | STAR-0215 |
BCX4161 is an investigational small molecule being developed for hereditary angioedema (HAE), a condition characterized by recurrent episodes of severe swelling. It is being studied as an oral prophylactic treatment to prevent HAE attacks. The drug is in Phase 2 clinical development and is not yet approved by regulatory authorities.
BCX4161 is being developed by BioCryst Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BCRX. The company is conducting clinical trials to evaluate the safety and efficacy of BCX4161 as a prophylactic treatment for hereditary angioedema.
BCX4161 is in Phase 2 clinical development for hereditary angioedema. It has completed four clinical trials, including two Phase 2 studies and two Phase 1 studies. The drug is investigational and has not received FDA approval, meaning it is still being evaluated in clinical trials.
BCX4161 has completed four clinical trials. These include NCT01984788, a Phase 2 safety and efficacy study as prophylaxis for HAE; NCT02125162, a Phase 1 bioavailability study; NCT02218294, a Phase 1 metabolism study; and NCT02303626, a 12-week Phase 2 study of oral prophylaxis against HAE attacks.
BCX4161 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for hereditary angioedema. All four of its clinical trials have been completed, but the drug has not yet received regulatory approval and remains under investigation for safety and efficacy.